EMA: No changes to the safety profile of Gardasil

09 February 2016

The European Medicines Agency (EMA) has recently completed its annual routine safety assessment of the HPV vaccine Gardasil®. The conclusion is that there are no changes to the safety profile.

In January 2016, the EMA’s Pharmacovigilance Risk Assessment Committee completed its annual routine assessment of the Periodic Safety Update Reports for the HPV vaccine Gardasil®. The conclusion is that the benefit/risk balance of the vaccine remains unchanged and consequently no changes to the product information of the vaccine are recommended.

In November, the EMA completed an extraordinary safety assessment upon a request from Denmark and found no evidence supporting a causal link between HPV vaccination and the two syndromes, CRPS and POTS.

Since HPV vaccination was implemented in the Danish childhood vaccination programme in 2009, the HPV vaccine Gardasil® has been used. Based on the most recent mandatory call for tenders for vaccines, the HPV vaccine Cervarix® is used in the Danish childhood vaccination programme from 1 February 2016. The safety of Cervarix is also monitored continuously, and the next routine safety assessment is expected in June 2016.

The Danish Medicines Agency and the EMA continue to closely monitor adverse reaction reports and knowledge about the safety of the vaccines.

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